Abstract:

There is provided a novel fitting having male and female ends and a
tapered internal luer-type seal. The male fitting end has a periphery
upon which is mounted at least one boss. The female fitting end has a
slot into which the boss may be inserted. At the bottom of the slot is a
stop to limit the insertion depth of the boss. The male and female ends
may then be rotated relative to each other to move the boss into a window
on the female end. The window has a frame and the upper frame is angled
slightly, corresponding to the boss, which serves to draw the male end
farther in to the female end. The window has a side frame that stops the
rotational movement of the boss. When the movement of the boss is
stopped, the male and female tapers are in substantially leak-free
contact. There is also provided a closed suction catheter using the novel
fitting, such that the catheter may be easily and quickly removed and
replaced.

Claims:

1. A quick connect fitting comprising a male fitting end having a body
with a periphery upon which is a boss, a female fitting end having a slot
corresponding with said boss and into which said boss may be advanced, a
stop on said female fitting end to limit the insertion depth of said boss
into said slot, a window into which the boss may be rotatably moved from
said slot to draw said male and female fitting ends closer together, and
corresponding luer tapers on said male and female fitting ends.

2. The fitting of claim 1 wherein said fitting comprises two bosses on
opposite sides of said male fitting end, and two corresponding windows on
said female fitting end.

3. The fitting of claim 2 wherein said bosses are of different sizes and
each said corresponding window are of a size corresponding to their
respective boss.

4. The fitting of claim 1 wherein said boss and window are at an angle
relative to a perpendicular from a centerline of said fitting of between
7 and 12 degrees.

5. The fitting of claim 1 wherein said boss and window are at an angle
relative to a perpendicular from a centerline of said fitting of between
9 and 10 degrees.

6. The fitting of claim 1 wherein said male and female fitting ends are
rotatably moved in a right hand turn orientation relative to each other.

7. The fitting of claim 5 wherein said fitting ends are moved by about a
quarter turn.

8. The fitting of claim 1 wherein said luer tapers are made from an
elastomeric material.

9. The fitting of claim 1 further comprising a surface treatment on either
or both of said luer tapers.

10. The fitting of claim 1 further comprising an O-ring placed around said
male fitting end luer taper to improve the seal.

11. The fitting of claim 1 which is adapted to connect a respiratory
system to a medical device.

12. A method of detachably connecting a male and female fitting end
comprising the steps of:inserting a male fitting end having a periphery
upon which is disposed a boss into a female fitting end upon which is
disposed a slot corresponding with said boss;advancing said boss to a
stop disposed on said female fitting end to limit the insertion depth of
said boss into said slot rotating said male fitting end relative to said
female fitting end to move said boss into a window disposed on said
female fitting end, said rotating also drawing together corresponding
luer tapers on said male and female ends;stopping the rotating of said
male fitting end relative to said female fitting end.

Description:

BACKGROUND

[0001]A number of medical devices may be attached to the respiratory
system of a patient while they are intubated with, for example, an
endotracheal tube. Desirably, these devices may be attached, used for a
period of time and detached for use elsewhere or for disposal. Various
types of detachable fittings or connectors are currently in use, however,
known fittings have a higher potential for failure than is desired due to
manipulation by the user or caregiver.

[0002]A luer taper is used in a standardized system of small-scale fluid
fittings used for making leak-free connections between a male-taper
fitting and its mating female part on medical and laboratory instruments,
including syringe tips, needles stopcocks and tubing. Luer taper fittings
commonly have a 6 percent taper and may be tested according to
(International Organization for Standardization) ISO 594-2. There are two
common varieties of luer taper connections; Luer Lok® and
Lure-Slip® fittings. Lure-Lok® fittings use a luer taper and are
securely joined by means of a tabbed hub on the female fitting which
engages threads in a sleeve on the male taper fitting. Luer-Slip®
fittings conform to luer taper dimensions and are simply held together by
friction. These luer fittings do not hold as well as would be desired and
sometimes may be dislodged relatively easily and inadvertently by the
patient or healthcare provider, resulting in the loss of ventilating
system pressure and potential exposure of healthcare providers to
communicable diseases of the patient. Luer fittings may also use standard
threaded connections that entail screwing together two parts a number of
turns to hold them securely but these fittings requires greater effort to
connect and are not considered "quick connect" fittings.

[0003]Bayonet fittings are also well known and accepted in the medical
field. Unfortunately, these fittings may be overridden in certain
applications, like respiratory applications, resulting in a broken
fitting and loss of ventilating system pressure.

[0004]Removing secretions from the tracheo-bronchial tree is an integral
part of the care given to patients who are intubated and receiving
mechanical or other artificial ventilation, for example. Secretions can
be excessive in some respiratory disorders and constitute a serious
threat to the patient having such respiratory disorders. The presence of
an endotracheal tube and the associated sedation is a hindrance to the
patient's efforts to clear secretions through natural coughing. In
current medical practice, suction catheters are inserted through the
endotracheal or tracheal tube into the trachea and main bronchus to clear
such secretions from the patient's airway by suctioning.

[0005]Suctioning may be performed using an "open" or "closed" system. In
the open system, the suction catheter is merely a flexible plastic tube
that is inserted into the tracheal tube ventilating lumen with a source
of suction connected to the proximal end of the suction catheter. The
suction catheter is advanced as far as desired and suction is applied to
remove secretions. Anything that the suction catheter touches before
entering the lumen must be maintained in a sterile condition so a
"sterile field" must be created on or next to the patient. The suction
catheter must be carefully handled after it is used since it will be
coated with the patient's secretions. In contrast, in the "closed"
system, for example that disclosed in commonly owned U.S. Pat. No.
4,569,344, a device 10 which may be used to suction secretions uses a
suction catheter 12 enclosed within a generally cylindrical plastic bag
14 to eliminate or minimize contamination of the suction catheter prior
to use (FIG. 1). This is generally referred to as a "closed suction
catheter" and is available under the trade name TRACH CARE® from
BALLARD® Medical Products (Kimberly-Clark Corporation). As the
patient requires artificial removal of secretions, the suction catheter
12 may be advanced through one end of the plastic bag 14, through a
connecting fitting 1 6, into the tracheal tube and, if desired, into one
of the main bronchi of the patient. The other, proximal end 17 of the
suction catheter 12 is attached to a source of suction 19. Suction is
applied to the proximal end 17 of the suction catheter 12 using a finger
controlled valve 18 to remove the secretions. The other bronchus may
likewise be aspirated. Secretions are thus drawn into the lumen of the
suction catheter 12 and removed and the system remains closed. The
suction catheter 12 is subsequently withdrawn from the tracheal tube and
back into the plastic bag 14 to keep the circuit closed. Closed suction
systems are generally preferred by healthcare providers since the
provider is better protected from the patient's secretions. Closed
suction systems are also easier and quicker to use since a sterile field
need not be created each time the patient must be suctioned, as is
required in open suction systems.

[0006]In order to change most current closed suction catheters, the
patient must be disconnected from the system for a period of time while
the ventilator is disconnected from the closed suction catheter that is
to be replaced and connected to the new closed suction catheter. The new
closed suction catheter is then connected to the endotracheal tube and
ventilating of the patient is begun again. This procedure is obviously
undesirable as it results in the patient being without mechanical
breathing assistance for a period and it exposes the healthcare provider
to the potentially communicable illnesses of the patient. Some closed
suction catheter systems use detachable fittings like bayonet fittings,
though, as mentioned above, these may have a higher potential for failure
than is desired.

[0007]It would be desirable to have a fitting that is reliable and quick
and easy to use. It would also be desirable to have a closed suction
catheter that could be quickly and easily replaced without disconnecting
the patient from the ventilating system.

SUMMARY

[0008]There is provided a novel fitting having male and female ends and a
tapered internal luer-type seal. The male fitting end has a periphery
upon which is mounted at least one boss. There may desirably be two
bosses on the periphery of opposite sides of the male fitting end, and
they may be of different lengths. The female fitting end has a slot into
which the boss may be inserted. At the bottom of the slot is a stop to
limit the insertion depth of the boss. The male and female ends may then
be rotated relative to each other to move the boss into a window on the
female end. The window has a frame and the upper frame is angled slightly
which serves to draw the male end farther into the female end. The window
has a side frame that stops the rotational movement of the boss. When the
movement of the boss is stopped, the male and female tapers are in
substantially leak-free contact.

[0009]There is also provided a closed suction catheter using the novel
fitting, such that the catheter may be securely connected yet easily and
quickly removed and replaced.

[0011]FIG. 2 is a drawing of the male fitting end of the novel quick
connect fitting.

[0012]FIG. 3 is a drawing of the female fitting end of the novel quick
connect fitting.

[0013]FIG. 4 shows the novel fitting described herein with the male
portion on the right side and the female portion on the left side.

[0014]FIG. 5 is a drawing of the male fitting end having permanently
attached thereto on its proximal end a closed suction catheter.

[0015]FIG. 6 is a drawing of the male fitting end having permanently
attached thereto on its proximal end a closed suction catheter and where
the male fitting end is releasably attached on its distal end to a female
fitting end that is connected to a manifold.

DETAILED DESCRIPTION

[0016]Reference is now made to the drawings wherein like numerals are used
to designate like parts throughout.

[0017]FIG. 1 illustrates an aspirating/ventilating apparatus disclosed
U.S. Pat. No. 4,569,344, also referred to under the trade name TRACH
CARE®. This closed suction catheter aspirating device 10 is attached
to the patient's endotracheal tube using a fitting 16 and may be included
as part of an overall ventilation circuit. The suction catheter 12 is
enclosed within a plastic bag 14 to eliminate or minimize contamination
of the catheter. As the patient requires artificial removal of
secretions, the suction catheter is advanced through the fitting 16 of
the ventilating device into the endotracheal tube (not shown), into the
patient's airway and then into one of the bracheal tube of the patient.
Suction is applied using a finger controlled valve 18 on the proximal end
of the catheter 12 to remove the secretions. The closed suction
aspirating device 10 of FIG. 1 may be used by attaching it directly to an
endotracheal tube or in other configurations as long as it may move in a
substantially straight alignment into the endotracheal tube. A more
detailed description of this care device may be found in U.S. Pat. No.
4,569,344.

[0018]FIG. 2 is a drawing of the male fitting end 80 of the novel quick
connect fitting. The male fitting end 80 tapers to a male luer taper 82
on its mating or distal end 84. On at least one side of the taper 82 is a
tab or boss 88 that is used to engage a female counterpart pocket or
slot. The boss 88 may be slightly angled relative to the perpendicular 98
of the centerline 90 of the male fitting end 80, indicated as angle "A",
to assist it in securely mating with the female fitting end. Also visible
on the proximal end 86 of the male fitting end 80 is an optional port 92
that may accommodate the irrigation line of a closed suction catheter
(not shown) for example as well as optional grip dimples 96 to aid in
gripping the piece with the hands.

[0019]FIG. 3 is a drawing of the female fitting end 100 of the novel quick
connect fitting. The female fitting end 100 has a pocket or slot 108 on
either side of its proximal end 106 that is sized to allow insertion of
the boss of the male fitting end. The female fitting end 100 has an
auto-alignment stop 112 that is located at the bottom of each slot 108 to
stop the movement of the male fitting end into the female fitting end
100. The female fitting end 100 further has a window 114 adjacent the
slot 108, and in communication such that the male fitting end boss may be
rotated into the window 114 once the boss is fully inserted and contacts
the auto-alignment stop 112. The window 114 has a proximal side frame 116
that is desirably at the same angle as the boss relative to a
perpendicular to the centerline 110 of the fitting. The window 114 has a
near side frame 118 adjacent the stop that allows the boss to enter the
window 114. The window 114 also has a far side frame 120 that stops the
rotational movement of the boss. The female fitting end 100 has a female
luer taper 102 located internally near the female fitting proximal end
106.

[0020]FIG. 4 is a drawing of the male fitting end 80 (distal end) engaged
with the female fitting end 100 (proximal end). As can be seen, the boss
88 is within the window frame 114. The male luer taper 82 is resting
against the inside of the female luer taper 102 (not visible).

[0021]The boss 88 on the male fitting end 80 may desirably be at an a
downward angle of from 5 to 15 degrees relative to the perpendicular of
the centerline 90 of the fitting to match the window 114 on the female
fitting end 100. More desirably the angle may be between 7 and 12 degrees
and still more desirably between 9 and 10 degrees. The male and female
fitting ends may be rotated relative to each other in a right hand turn
orientation to tighten them, desirably for about a quarter turn though
more or less may be desirable in particular applications. A left hand
turn orientation may also be used if desired.

[0022]In usage, once the boss of the male fitting end is inserted into the
slot of the female fitting, it may advance only so far as to contact the
stop at the bottom of the slot. The stop is placed at the proper depth so
as to bring the luer tapers of the male and female fittings close
together or into contact. Once the boss is fully inserted into the slot,
the male fitting end may be rotated in only one direction relative to the
female fitting to move the boss into position in the window. As the boss
moves into the window, contact with the upper (angled) frame of the
window causes the entire male fitting end to move slightly farther into
the female fitting end. When the boss contacts the far window side frame
movement is stopped and the tapers of the male fitting end and the female
fitting end are fully engaged and are in substantially leak-free contact.

[0023]Should additional sealing capability be desired an O-ring type
sealing system may be added to the novel fitting. In this embodiment an
elastomeric O-ring may be placed over the luer taper of the male fitting
end so that it will be compressed by the male and female fitting ends
when they are fully engaged, and so improve the seal. Additional sealing
and flexibility may also be added by making either the luer taper of the
male fitting end or the female fitting end (or both) from an elastomeric
material.

[0024]In still another embodiment, a surface treatment substance or
texture may be added to either or both tapers to increase the seal
created upon full engagement.

[0025]It should be appreciated that although the term "window" is used
herein, it is not meant to imply that it comprises is a passageway from
outside the fitting to inside the fitting, though for ease of
manufacturing the open window is desirable. The window may be sealed from
the outside (or closed) and only open toward the inside of the fitting so
that the boss may rotate into the window.

[0026]It should also be noted that, though the drawings reference only two
bosses on the male end there could be one, three or four if there were
enough space on the periphery of the fitting and if this were desired for
some reason. It should also be noted that the bosses could be of
different widths and the slots could be of correspondingly different
widths so that the male fitting could be inserted into the female fitting
in only one orientation. Stated another way, if more than one boss were
present, one boss could be longer than the other and only fit into one
slot sized especially for that longer boss. There would then be only one
position in which the male fitting could be inserted into the female
fitting.

[0027]The novel connector described can be used to connect a closed
suction catheter to a ventilating circuit. Turning to FIG. 5, one can
easily see that a closed suction catheter 12 in a plastic bag 14 may be
permanently attached to, for example a male (or female) fitting end 80
described above on its proximal end. A number of other features of the
male fitting end 80 are visible in this FIG. 5 including the grip dimples
96, boss 88, male luer taper 82 and the irrigation port 94. The mating
fitting end may be permanently attached to the ventilating circuit. After
a period of time or if the healthcare provider deems the catheter to need
replacement, the male and female fittings may be quickly and easily
disengaged and a new catheter attached. FIG. 6 is a drawing of the male
fitting end 80 having permanently attached a closed suction catheter 12
in its plastic bag 14 on its proximal end and being releasably attached
to a female fitting end 100 on its distal end. The female fitting end 100
is permanently attached to a respiratory manifold assembly 20. The
assembly 20 may contain an elbow type connector 22, a rotating manifold
33, and ports 28, 30 and 32. The elbow 22 has a distal port 24 that
connects to a tracheal tube and a proximal port 26 for connection to a
mechanical ventilator.

[0028]The materials of construction of the novel connector may be
conventional polymeric materials. A suitable polymer is available under
the trade name LEXAN® polycarbonate. Other materials from which the
connector may be made include polyethylene, polypropylene, acrylic,
polyethylene terephthalate, polyurethane, nylon and styrene.

[0029]Modifications and variations of the presently disclosed device will
be obvious to those of skill in the art from the foregoing detailed
description. For example, though the discussion above mentions the quick
connection of catheters, other devices such as cameras or other viewing
devices may be connected to a ventilating system, provided they are of
the appropriate size. The quick connection device described herein may
also be used in applications other than respiratory care. Such
modifications and variations are intended to come within the scope of the
following claims.